Does anyone have any thoughts on this morning's press release?
Why did they wait until November 11 to announce that they were resubmitting?
Tuesday November 11, 8:32 am Eastern Time
Company Press Release
SOURCE: Cephalon, Inc.
Cephalon and Chiron Resubmit Myotrophin NDA To Extend FDA Review
WEST CHESTER, Pa., and EMERYVILLE, Calif., Nov. 11 /PRNewswire/ -- Cephalon, Inc. (Nasdaq: CEPH - news) and Chiron Corporation (Nasdaq: CHIR - news) announced today that they have withdrawn and resubmitted to the U.S. Food and Drug Administration the companies' new drug application (NDA) to market MYOTROPHIN(R) (mecasermin) Injection in the United States for the treatment of ALS. By withdrawing and resubmitting the NDA, the companies will enable the FDA to continue its review. Under the Prescription Drug User Fee Act, which establishes performance goals for FDA reviews of new product applications, the FDA's review of the MYOTROPHIN NDA was expected to be completed by November 11, 1997.
The FDA informed the companies that information submitted in support of the MYOTROPHIN NDA requires more in-depth analysis by the agency before a final decision on the NDA can be made.
Cephalon President Frank Baldino, Jr., Ph.D., and Chiron Technologies President Lewis T. Williams, M.D., Ph.D., stated: ''Although this action is unusual, it provides the FDA adequate time to evaluate all the data submitted in support of the NDA. We have been advised that the FDA will complete its review of the data and reach a decision on the NDA promptly.''
Cephalon and Chiron are developing MYOTROPHIN Injection in North America and Europe for the treatment of ALS and other neuromuscular disorders.
Chiron Corporation, headquartered in Emeryville, Calif., is a healthcare company that combines diagnostic, vaccine and therapeutic strategies for controlling disease.
Cephalon, Inc., headquartered in West Chester, Pa., is an international biopharmaceutical company that discovers, develops and markets products to treat neurological disorders. The company is developing products for the treatment of amyotrophic lateral sclerosis, narcolepsy, peripheral neuropathies, Alzheimer's disease and stroke. Cephalon currently copromotes three products in the United States for the treatment of neurological conditions.
This news release may contain forward-looking statements that involve risks and uncertainties. A full discussion of Cephalon's and Chiron's operations and financial condition, including factors that may affect the companies' business and future prospects, is contained in documents the two companies file with the SEC, such as form 10-Q and 10-K reports. These documents identify important factors that could cause their actual performance to differ from current expectations.
NOTE: Cephalon's press releases are available by fax 24 hours a day at no charge by calling PR Newswire's Company News On-Call at 800-758-5804, extension 134563. They we also posted on the Internet at prnewswire.com.
SOURCE: Cephalon, Inc.
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